ImmunoCAP® Specific IgE Blood Test

What is the ImmunoCAP® Specific IgE blood test?

A laboratory test to rule in or rule out atopy in patients with allergy-like symptoms. ImmunoCAP® provides a clinically relevant means of confirming or excluding the presence of atopic disease in patients with upper respiratory disease. These allergy-like symptoms are very difficult to differentiate. ImmunoCAP® will accurately identify specific allergen sensitivities in patients with confirmed allergies.

What does the test measure?

This in vitro quantitative assay measures allergen specific IgE in human serum. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings. ImmunoCAP® assays can be performed on hundreds of allergens such as weeds, trees, pollens, mold, food, and animal dander.

What is the role of this test in diagnosing and managing upper respiratory disease?

Causes of nasal symptoms associated with upper respiratory disease (URD) can range from aspirin intolerance to pregnancy. The exact etiology of allergy-like symptoms is often difficult to determine definitively. The origin could be allergic, bacterial, viral, or pathological and is virtually impossible to establish with an empirical assessment alone. Compounding this, consumer awareness is at an all-time high. Patients often come in with pre-determined self-diagnosis and request for therapy. History and physical are important, but further inquiry is often necessary to provide an evidence-based diagnosis and treatment regimen. ImmunoCAP® Specific IgE blood test can definitively rule in or rule out atopic disease as the cause of or contributing factor to these symptoms.

Once a definitive diagnosis is reached, regardless of the presence or absence of atopy, appropriate treatment options can be employed. When atopy proves to be a factor in URD, avoidance is considered the primary therapeutic approach by all leading professional allergy associations. This test can identify the specific causative allergens.

How does this test compare with other technologies?

The technology used in ImmunoCAP® is a vast improvement over earlier blood allergy testing (RAST®). In fact, ImmunoCAP® has recently been cleared by the FDA to provide quantitative measurement of IgE. This means ImmunoCAP® can quantitatively and accurately determine if patients are allergic and exactly what they are allergic to. A recent study published in the Journal of Allergy and Clinical Immunology demonstrated that ImmunoCAP® is the standard for accuracy and reliability for quantitative IgE testing.

The basis of the innovative ImmunoCAP® technology is a cellulose polymer in a plastic reserve. This unique technology provides high binding capacity of clinically relevant allergen proteins, including those present in very low levels. This provides accurate results and increased sensitivity, specificity, and reproducibility, equaling the most advance in vitro testing available today.

Why should I incorporate this test in my practice?

Your daily practice routinely includes patients who present with URD: rhinitis, sinusitis, and allergic rhinitis. The source of their symptoms may be viral, bacterial, or allergic, making definitive diagnosis an essential step in determining appropriate treatment. More than a nuisance, these conditions affect tens of millions of Americans; have a significant impact on quality of life, and result in billions of dollars in direct and indirect costs. Allergy awareness among the general population is at an all-time high, and patients and clinicians want to get to the cause of respiratory distress. Now more than ever, URD management is an important part of the primary care practice. ImmunoCAP® provides quantitative evidence that clearly demonstrates the appropriateness and value of your patient's treatment plan. The right treatment decisions, based on clinical evidence, means appropriate use of antibiotics, antihistamines, and intranasal steroids, fewer repeat office visits, and fewer unnecessary referrals.

Who should be tested?

Anyone presenting with nasal or other allergy-like symptoms is a candidate for specific IgE testing. However, ImmunoCAP® Specific IgE blood test should be strongly considered for patients with:

• recurrent or chronic URD, i.e. rhinitis, sinusitis, allergic-rhinitis
• unseasonal allergy-like symptoms
• seasonal or perennial allergy-like symptoms
• recurrent otitis media
• exogenous asthma and other conditions in which IgE mediation is suspected

The test can be run on patients of any age and regardless of skin condition. There is no need to stop current medications prior to drawing a blood sample.

What are the specimen requirements?

The specimen requirements are 3-5 mL serum; transport specimen refrigerated.

How do I order the test?

While you can choose from hundreds of allergens, most patients presenting with nasal symptoms can be tested effectively with the regional Upper Respiratory Allergy Profile consisting of 14 of the most common inhalant allergenics specific to our region, along with total IgE. For more information on how to order the ImmunoCAP® IgE specific blood test, including the regional Upper Respiratory Allergy Profile or individual allergens, please contact your local Interpath Client Services representative 1 (800) 700-6891.

Tools to assist the physician

Interpath and Pharmacia Diagnostics have teamed up to provide tools to assist physicians with the diagnosis and management of Upper Respiratory Diseases.

URD

Upper Respiratory Allergy Profile
Upper Respiratory Allergy Patient Management
Negative Result Treatment Pathways
Get to the true cause of Upper Respiratory Disease
Interpretation Guidelines
"Published Support for Evidence-Based Diagnosis in Upper Respiratory Disease"

CHILDHOOD DISEASES

A Childhood Allergy (Food/Environmental) Profile
Learn how early recognition of underlying atopy can change the course of the Allergy March.
Interpretation Guidelines

FOOD ALLERGIES

A Food Allergy Profile, Adult
Interpretation Guidelines

TECHNICAL SUPPORT

"Published Support for Diagnosis of Underlying Atopy in Common Childhood Diseases"
"Published Support for Evidence-Based Diagnosis in Upper Respiratory Disease"

BILLING INFORMATION

ICD-9 and CPT Code Lists

OTHER INFORMATION

Visit the PubMed site to read the following abstracts
"Precision and accuracy of commercial laboratories' ability to classify positive and/or negative allergen-specific IgE results"
"Analytic precision and accuracy of commercial immunoassays for specific IgE: Establishing a standard"
"A comparison of skin prick tests, intra dermal skin tests, and RASTs in the diagnosis of cat allergy"

Visit www.isitallergy.com for:
1. Information on the relationship between atopy and childhood disease, including symptoms, the Allergy March and testing options.
2. Case studies that highlight the value of evidence-based decision-making using ImmunoCAP® Specific IgE blood test technology, including interpretation of results, clinical diagnosis, and treatment.